Effect of Tai Chi Exercise Intervention on Physical and Mental Distress of Patients With Colorectal Cancer During Adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Fatigue Measured by the Brief Fatigue Inventory-Taiwan Form
研究概览
简要总结
Colorectal cancer patients receiving adjuvant chemotherapy may experience reduced physical fitness, fatigue, emotional distress, sleep problems, and impaired quality of life. This study evaluated whether a 24-week Tai Chi exercise program could improve physical and psychological outcomes in patients with colorectal cancer undergoing adjuvant chemotherapy.
Participants were randomly assigned to either a Tai Chi exercise group or a usual-care control group. Participants in the Tai Chi group were instructed to perform at least 150 minutes of Tai Chi exercise per week for 24 weeks, while participants in the control group received usual care. Physical fitness, fatigue, depression, anxiety, sleep quality, and quality of life were assessed during the study.
详细描述
This study used a randomized, two-group, repeated-measures design to evaluate the effects of a 24-week Tai Chi exercise program in patients with colorectal cancer undergoing adjuvant chemotherapy.
Eligible participants were adults aged 20 years or older who had undergone colorectal cancer surgery for the first time and were scheduled to receive six months of adjuvant chemotherapy. Participants were randomly assigned to the Tai Chi exercise group or the usual-care control group using a computer-generated random-number procedure.
Participants assigned to the intervention group received usual care and participated in a 24-week Tai Chi exercise program. They were instructed to complete at least 150 minutes of Tai Chi exercise per week. The exercise could be completed in one or multiple sessions according to the participant's physical condition and treatment schedule. Participants received an instructional video and manual, recorded their daily exercise duration, and were contacted weekly by telephone to assess adherence and address difficulties encountered during exercise.
Participants assigned to the control group received usual care during adjuvant chemotherapy and did not receive the structured Tai Chi exercise program.
Study outcomes included upper- and lower-extremity muscle strength, static and dynamic balance, fatigue, depression, anxiety, sleep quality, and quality of life. Assessments were conducted before the first adjuvant chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 years or older
- •Underwent colorectal cancer surgery for the first time
- •Scheduled to receive six months of adjuvant chemotherapy following colorectal cancer surgery
- •No other serious medical condition
- •No acute functional decline during hospitalization
- •Willing to participate and able to provide written informed consent after receiving an explanation of the study
- •Able to communicate in Mandarin Chinese or Taiwanese
- •Clinically stable and receiving regular outpatient follow-up
排除标准
- •Required radiotherapy or targeted therapy in addition to adjuvant chemotherapy after surgery
- •Admitted to an intensive care unit because of trauma surgery, heart failure, end-stage disease, or another serious condition
- •Valvular heart disease, atrial fibrillation, cardiomyopathy, myocarditis, uncontrolled chronic disease, or congestive heart failure
- •Unable to clearly communicate level of consciousness, symptoms, or feelings
- •Severe visual or hearing impairment
- •Diagnosed psychiatric disorder
- •Medically advised not to exercise
研究组 & 干预措施
Tai Chi Exercise Group
Participants received usual care and completed a 24-week Tai Chi exercise program, with a target of at least 150 minutes of Tai Chi exercise per week.
干预措施: Tai Chi Exercise Program (Behavioral)
Usual Care Control Group
Participants received usual care during adjuvant chemotherapy and did not receive the structured Tai Chi exercise program.
结局指标
主要结局
Change in Fatigue Measured by the Brief Fatigue Inventory-Taiwan Form
时间窗: Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
Fatigue was assessed using the Brief Fatigue Inventory-Taiwan Form. The instrument contains three items assessing fatigue severity and six items assessing interference of fatigue with daily functioning. Each item is rated from 0 to 10, with higher scores indicating greater fatigue severity or interference. Mean fatigue severity and fatigue interference scores were calculated.
次要结局
- Change in Grip Strength(Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks)
- Change in Lower-Extremity Muscle Strength Measured by the 30-Second Chair Stand Test(Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks)
- Change in Depression Severity Measured by the Beck Depression Inventory-II(Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks)
- Change in Anxiety Severity Measured by the Beck Anxiety Inventory(Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks)
- Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index(Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks)
- Change in Health-Related Quality of Life Measured by the EORTC QLQ-C30(Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks)
研究者
Ya-Fen Fan
Assistant Professor, Department of Nursing
MacKay Junior College of Medicine, Nursing, and Management